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The landscape of regenerative medicine is evolving rapidly and changing the paradigm of healthcare. Potential cures, and the subsequent opportunity to continue to embrace life, could be in sight for patients with severe and rare diseases.

The FDA is set to approve up to nine cell and gene therapies in 2023, a record for the most approved in a year, according to the Alliance for Regenerative Medicine (ARM), the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines. Many of these therapies are for rare diseases. The pace is not expected to slow appreciably in coming years.

Yet, due to the tremendous growth in the number of cell and gene therapy developers and concomitant clinical trials, this biotech sector faces a workforce crunch, which is most predominant in technical areas such as development and manufacturing. The critical skills identified in ARM’s August 2023 Sector Snapshot include quality control and assurance, manufacturing, and process and analytical development.

Connecting the Dots between Concept and Realization

With over 50 years of scientific expertise in biotechnology Rentschler Biopharma, a family-owned CDMO, partners with entrepreneurial gene and cell therapy companies to fill the critical skill gap identified by ARM. Importantly, this service offering is bioprocess development through to cGMP ATMP (advanced therapy medicinal products) manufacturing at the CDMO’s MHRA-approved, Stevenage, U.K.-based facility.

Rentschler firmly supports value creation and goes beyond to enable companies to progress their ideas and science into transformative medicines, according to Kassim Kolia, Vice President of Business Development for the ATMP business. “We believe that our purpose is not just to offer services, but to connect the dots between concept and realization,” Kolia said. “Through meticulous collaboration, scientific excellence, and dedication, we stand committed to narrowing the current gap in gene therapy expertise.”

Communication, Scientific Expertise, and Transparency

Kolia emphasized that by ensuring that innovative translational research evolves into bedside solutions, the company aims to be a major support system in propelling its partners towards their aspirations in serving the needs of patients with serious and rare diseases. “To achieve this at Rentschler Biopharma, we focus on various elements to ensure success, knowing that communication, scientific expertise, and transparency are crucial to any CDMO relationship,” Kolia added.

The tailored and collaborative experience is designed for companies that do not want to get lost in the queue of a less nimble CDMO focused on predominantly large-dollar and large-scale manufacturing projects.

This message resonates with the marketplace, especially companies that want to devote their limited internal resources to crucial preclinical scientific pursuits, Kolia maintained, noting that these entrepreneurial companies prefer to team up with a trusted partner that has the experience and expertise in development and manufacturing they need, to turn their knowledge into products for clinical trials and beyond.

For example, Ikarovec, a preclinical phase gene therapy company, entered its relationship with Rentschler Biopharm with an eye on its future. “As we look to find new and better ways to treat ophthalmic diseases, we want to get it right and ensure that our product candidates can be scaled up appropriately for each development stage and, ultimately, for commercialization,” said Katie Binley, PhD, Chief Scientific Officer of Ikarovec.

Saving lives is the end goal. As Kolia stated, Rentschler Biopharma works to connect the dots between concept and realization with its team of experienced scientists who not only support the bioprocess development and production of gene therapies, but also have the expertise to tackle and resolve challenges that always arise during the journey.


Reach out to Rentschler Biopharma for your AAV-vector-based gene therapy projects www.rentschler-biopharma.com

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